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Plant Stanol Esters and Influenza Vaccination

NCT ID: NCT05706350

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2022-12-20

Brief Summary

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Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI and age have previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.

Detailed Description

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Conditions

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Immune Response

Keywords

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Plant Stanols Immune system Influenza vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Plant stanol group (2 grams per day)

Dietary Supplement: 4 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Plant stanol soft chews (2g per day)

Intervention Type DIETARY_SUPPLEMENT

Participants have to consume 4 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 2g daily

Plant stanol group (3 grams per day)

Dietary Supplement: 6 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Plant stanol soft chews (3g per day)

Intervention Type DIETARY_SUPPLEMENT

Participants have to consume 6 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 3g daily

Plant stanol group (4 grams per day)

Dietary Supplement: 8 soft chews containing 0.5g plant stanols each (delivered as plant stanol esters) Soft chews containing 0.5g plant stanols each delivered as plant stanol esters

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Plant stanol soft chews (4g per day)

Intervention Type DIETARY_SUPPLEMENT

Participants have to consume 8 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 4g daily

Placebo group

Dietary Supplement: 6 placebo soft chews Soft chews that do not contain plant stanols

Group Type PLACEBO_COMPARATOR

Influenza vaccine

Intervention Type BIOLOGICAL

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Control soft chews

Intervention Type DIETARY_SUPPLEMENT

Participants have to consume 6 control soft chews per day that does not contain plant stanols

Interventions

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Influenza vaccine

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Intervention Type BIOLOGICAL

Plant stanol soft chews (2g per day)

Participants have to consume 4 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 2g daily

Intervention Type DIETARY_SUPPLEMENT

Plant stanol soft chews (3g per day)

Participants have to consume 6 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 3g daily

Intervention Type DIETARY_SUPPLEMENT

Plant stanol soft chews (4g per day)

Participants have to consume 8 soft chews per day containing 0.5g plant stanols each (delivered as plant stanol esters), corresponding to a total plant stanol intake of 4g daily

Intervention Type DIETARY_SUPPLEMENT

Control soft chews

Participants have to consume 6 control soft chews per day that does not contain plant stanols

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Aged 60 years or older (or 59, but turning 60 years during influenza season 2022/2023 (in line with RIVM guidelines))
* BMI between 20 and 35 kg/m2
* Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to keep the intake of fish oil and vitamin supplements constant

Exclusion Criteria

* Already received influenza vaccination in 2022
* Already had influenza in 2022
* Allergy to an ingredient of the chews
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft and/or hard drugs
Minimum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Raisio Nutrition Ltd.

UNKNOWN

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METC 22-048

Identifier Type: -

Identifier Source: org_study_id